My name is Mike Ushay from the Children's Hospital of Montefiore in the Bronx, New York. I'm going to talk to you today about ethical issues in pediatric critical care medicine. I have no conflicts of interest to report. As of 2020, the American Board of Pediatrics has reported that about a total of 5% of the certification exam in pediatric critical care medicine would deal with end-of-life issues at about 4% and clinical ethics about 1%. I hope to cover many of these topics today in this lecture. Specifically in regarding clinical ethics, I hope to talk about core principles of medical ethics, ethical and legal principles regarding putile and potentially inappropriate care, and principles of consent and assent, among others. Let's begin with a question. A three-year-old girl is in a persistent vegetative state and ventilator dependent after prolonged status epilepticus. Physicians have told mother there is no hope for meaningful recovery. In several multidisciplinary family meetings, mother requested the ventilator be removed to end her suffering and let her die. All involved parties, including the Pediatric Ethics Committee, agree. Mechanical ventilation is discontinued with appropriate administration of IV morphine to ensure there is no pain and to reduce gasping. Which standard for decision-making in the presence of a patient without capacity was used in this case? 1. Substituted judgment. 2. Best interest. 3. Paternalism. 4. Justice. 5. Respect for autonomy. The answer here is number two, best interest. Much of our practice in pediatric critical care medicine, and in pediatrics as well, involves making decisions for those who can't decide for themselves. And it involves a constant weighing of the best interest standard versus the substituted judgment standard. In surrogate decision-making, the substituted judgment standard and the best interest standard are the two major ways in which decisions are made for those who do not have capacity to make decisions for themselves. The substituted judgment standard involves asking what would the patient have wanted done or not done? Had they been able to answer that question or been asked a particular question? The best interest standard, which has much more implication in pediatrics, involves what is in the perceived best interest of the patient. There are concerns in biomedical ethics which are specifically relevant to children. One is that we are dealing with decision-making for the never-capacitated individual. We are always using surrogate decision-makers. On top of this, there's the developmental continuum, which increases the role of the patient in the decision-making process through growth. And as pediatricians, we have responsibilities not only to the patient, but also to the parents. Confidentiality in the adolescent patient is a very significant issue. As we know, the prognoses of complex illnesses constantly change, and it becomes hard to predict sometimes. The role of children as research subjects is very important to us as academicians. Children as a source and recipient of tissues and organs has ethical implications, as well as genomics and genetic testing, which, as we know, are being used more and more frequently. There are several foundations which can be used to approach bioethics. One of the most popular is the principles-based approach, or principlist approach. The well-known and well-oft-recited principles of autonomy, beneficence, non-maleficence, and justice were described by Beauchamp and Childress in their textbook, Principles of Biomedical Ethics. Autonomy involves respect for the individual and for that person to be the agent to make decisions for their health care and what should happen to their person. Beneficence refers to always doing good for our patients. Non-maleficence means that we should never intentionally do bad to our patients. And justice involves treating all patients equally. Another question. A 10-year-old boy has been on VV ECMO for 45 days with severe PARDS due to idiopathic pneumonia syndrome status post an allogeneic hematopoietic stem cell transplant for acute myelocytic leukemia. There has been no recovery of lung function, and a decision is made to withdraw support. The patient is made DNR, DNI. A plan is enacted with the palliative care team to treat post-withdrawal dyspnea and gasping with doses of IV morphine. The patient is decannulated and extubated, and after IV and nebulized morphine are administered to ensure comfort, he expires. In the debrief, a medical student on the team expresses his comfort in that it appears that the morphine may have contributed to the patient's death. You explain that the use of morphine, as well as other sedatives, is ethically permissible in this situation due to, one, non-maleficence, two, beneficence, three, the principle of double effect, or four, justice. The answer here is number three, the principle of double effect. The doctrine of double effect originated in the 13th century in the writings of Thomas Aquinas, and has been accepted through subsequent history by faith traditions and cultures as a way of justifying an action which may have a bad or good end result, as long as the good effect or the good result is what is intended. Let's look at this doctrine of double effect in relation to the administration of morphine or other pain medication to a patient who was dying in pain and in respiratory distress. Number one, the act of giving morphine or pain medication must be morally good, or at least neutral. Number two, the good effect, that is, relief of pain or dyspnea, is what is intended. Number three, the bad effect, hypopnea, hypotension, potentially resulting in death, is merely foreseen. The bad effect is not the means to the good effect. It is not intended. And number five, in the principle of proportionality, the good of the action must outweigh the bad. The U.S. Supreme Court has ruled on and supported the doctrine of double effect. It is widely recognized that the provision of pain medication is ethically and professionally acceptable, even when treatment may hasten the patient's death, if the medication is intended to alleviate pain and severe discomfort, not to cause death. And that's from the case of Vaco v. Quill in the writings of Chief Justice Rehnquist. With regard to the use of paralytics in the dying process, do not give paralytics during the dying process to patients who have not already been receiving them. In general, when patients have been receiving paralytics, withdrawal of life support should be delayed until the paralysis is worn off or been reversed. And when waiting would require an unacceptable delay in withdrawal of life support, withdrawal may proceed with careful attention to the patient's comfort. I would like to review the Baby Doe case. This case, which occurred 40 years ago in Indiana, has ancient history by our life in critical care medicine. However, this case represented some of the beginnings of bioethics in pediatrics. And downstream effects of this case still affect our practice to this day, although to a limited extent. So let's go over this. Baby Doe was an infant with Down syndrome who was born in Indiana in the spring of 82. The baby had a TEF with esophageal atresia, type C, and could not feed or drink. The parents opted against surgery. They administered morphine and phenobarbital for comfort. The pediatrician sought a court order to remove parental custody at least temporarily and authorize surgery. The Indiana courts supported the family's decision. And while the appeal was going to the US Supreme Court, Baby Doe died at six days of life. Some of the things that are important about this case are that within historical context, this was an era when limitations of care was the hot issue in biomedical ethics. President Reagan and the Surgeon General at the time, C. Everett Koop, who some of you may remember was a very highly regarded pediatric surgeon, maybe one of the top pediatric surgeons in the country, concluded that parents and health care providers could not be trusted to use a best interest standard to make good decisions for imperiled infants. They directed Health and Human Services to propose regulations to prevent withholding care from what they classified as imperiled newborns. They used the 1973 Rehabilitation Act, specifically Section 504, which prohibited discrimination against people with disabilities. And they required that all potentially efficacious lifesaving treatments be administered with no quality of life consideration. The Baby Doe regulations, as they were called, required maximal treatment in all except futile cases. And futile was defined as meaning irreversibly and imminently dying. They placed signs in neonatal units that discriminatory failure to feed or care for handicapped infants in this facility is prohibited by federal law. There was a phone number attached with this sign. And Baby Doe squads could be dispatched upon receipt of phone calls from concerned people. The President's Committee for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research met in March 1983 and recommended full treatment for infants with trisomy 21, but did realize that latitude was necessary in common. The Baby Doe case was followed a year later by the Baby Jane Doe case. This was an infant born with spina bifida and hydrocephalus. The parents opted against a shunt and closure of the meningomyelocele. HHS was informed through the hotline. An attorney filed suit to have surgery done. HHS brought the suit to the U.S. District Court and the court ruled for the hospital and the family. They felt there was no discrimination. It was a reasonable decision and was done in the best interest of the patient. The U.S. Court of Appeals ruled the government did not have authority to give unsolicited advice to those who are faced with difficult decisions. In 1984, Health and Human Services modified the 1977 Child Abuse Protection and Treatment Act called CAPTA. In their modification, they stated that extremely ill, premature, or terminally ill infants under one year must receive nutrition, hydration, and medication, all medically indicated treatment. That treatment was not medically indicated if the patient was in a chronic and irreversible coma, if it would prolong dying, not correct all life-threatening conditions, or was futile, or if the treatment was inhumane and virtually futile. This is federal law and it still exists to this day. This act was a federal requirement for states to receive grants from the federal government. CAPTA has been revised several times or multiple times subsequently, continues to be revised, but it is not the law of the United States. The 1984 modifications permitted reasonable medical judgment by a prudent physician with knowledge about the case and treatments, did not permit quality-of-life arguments, but also recognized that the parents play a role. Although they didn't provide funding for it, it did recognize that aid and supportive services were important and that families should be provided current and comprehensive knowledge. It is very rare to hear baby Doe discussed anymore. In our current time, decision-making about critically ill and handicapped infants is much more collaborative and it's difficult to find cases of withholding life-sustaining treatment based on Down syndrome or spina bifida. The cases that neonatologists face now are much more complex. They involve extremely low birth weight, intracranial hemorrhages, multi-organ system failures, and trisomies. In 2005, the President's Council on Bioethics reinforced strict interpretation of the baby Doe rules while supporting much more personal choice and end-of-life care in adults. It provided a broader interpretation of the best interest standard for adults than for children. Decision-making in pediatrics. We are always dealing with surrogate decision-making, comparing the best interest standard versus the substituted judgment standard. Parents act in the best interest of their child almost always, but it's not guaranteed, and this adds to the challenge of our careers as pediatricians when we often have to make these evaluations. Parents may martyr themselves, but may not make martyrs of their children, as was discussed in the 1944 Supreme Court case of Prince v. Massachusetts. The courts have given wider latitude in non-religious cases and in cases involving adolescents. And the word martyr here indicates specifically cases with religious impact. Each state has different rules and regulations regarding decision-making with children. In 2010, my state, New York, brought the Family Health Care Decision Act into law. And this act states that a parent or guardian of a minor patient shall have the authority to make decisions about life-sustaining treatment, including decisions to withhold or withdraw such treatment. A parent or guardian of a minor patient shall make decisions in accordance with the minor's best interests, taking into account the minor's wishes as appropriate under the circumstances. The AAP published their recommendations on decision-making in critical illness in 1996. In their statement, they said that decisions for newborns, infants, and children should be made similarly and with informed parental permission. Provision or foregoing of critical care services should be based on projected benefits and burdens of treatment. Parents and patients may perceive and value benefits and burdens differently than medical professionals. And decisions to forego critical care services based on resource limitations generally are not clinical decisions, and physicians should avoid bedside. Another question. A three-year-old girl is in a persistent vegetative state and ventilator-dependent after prolonged status epileptics. In several multidisciplinary family meetings, physicians have told mother there is no hope for meaningful recovery and that it is an option to remove the child from the ventilator, knowing that the patient will likely die. The mother requests that the ventilator be removed to end her daughter's suffering and let her die. All involved parties, including the Pediatric Ethics Committee, agree that patients may DNR, DNI, and mechanical ventilation discontinued with appropriate administration of morphine to ensure there is no pain. Which of the following best describes the process used to arrive at this conclusion? 1. Patient and parental autonomy 2. Paternalism 3. Shared decision-making 4. Family-centered care 5. Non-maleficence The correct answer is number three, shared decision-making. Historically, medicine was very paternalistic. Doctors told patients what they could or could not do or what they could or could not have. This transitioned with a strong emphasis to autonomy to what is sometimes referred to as menu-choice autonomy, in which we as physicians would give patients and families a choice of possible choices without a recommendation for what we thought was the better or best choice, often leaving families sort of adrift and in a wash of a lot of decisions to make and without necessarily appropriate guidance. This has transitioned to a more contemporary approach called shared decision-making, which is now emphasized in pediatric and adult medicine. This has transitioned to a more contemporary approach called shared decision-making, which is now emphasized in pediatric and adult biomedical ethics and care, in which we as healthcare providers share information, obtain information from our families and parents, and can give our recommendations for what we think is clinically the best option, but understanding and respecting the decisions that the families and proxies may return with. This is a rubric obtained from Cassidy and Fleischman's textbook on treatment options for seriously ill children, looking at physicians' assessment in relation to parents' preference. It can be somewhat helpful and just like to give it to you as background information. If a physician believes a treatment is clearly beneficial and the parents wish to get the treatment, then it is good and appropriate to provide the treatment. If ambiguity exists and the outcome is uncertain, if the families just wish to proceed, treatment can be provided. But in an ambiguous situation, the parents prefer to forego treatment, treatment can be forgone. If treatment is judged to be futile, and the parents prefer to provide treatment, provide treatment unless the provider declines to do so. But if the parents prefer to forego treatment, forego the treatment. This is a case of parental refusal of a liver transplant for a child with biliary atresia. Parents refuse surgery for what they thought were appropriate reasons. The physicians caring for the child stated that liver transplant was the standard of care, and they would try to come to an accommodation through education and discussion. But they just wanted to think about whether it was appropriate to report the child to CPS as neglect. In another case published in Pediatrics, can parents refuse a potentially life-saving transplant for severe combined immunodeficiency? What are the limits of parental discretion in health care decision making for children? We can think about it in several ways. When is the treatment ethically obligatory? When is a treatment ethically optional? And when is a treatment ethically inappropriate? This slide provided to me by Dr. Alan Fleischman helps us decide on these issues. What are the limits of parental discretion? If a treatment is ethically obligatory, parents may not refuse it. It has, if it is clearly beneficial and of modest risk. If the treatment is ethically inappropriate, parents may not demand it. If it's clearly non-beneficial, thought to be futile, and clearly not in the best interest of the child. In the middle, we have the treatments which are ethically optional, and it becomes a little bit tricky here. Parents may decide to consent or refuse in situations where there's marginal or uncertain benefit and uncertain risk. The American Academy of Pediatrics has provided guidance on foregoing life-sustaining medical treatment. In their statement, they said that foregoing life-sustaining medical treatment is ethically supportable when the burdens of treatment outweigh the benefits to the child. It may be ethically supportable to forego life-sustaining medical treatment without family agreement in rare circumstances of extreme burden of treatment with no benefit to the patient beyond postponement of death. When prognosis is uncertain but likely to be very poor, and survival may be accompanied by a high risk of permanent and severe diminished quality of life, it is ethically supportable for decisions about foregoing life-sustaining medical treatment to be determined by parental preferences, except when requested treatments are judged to be of net harm, no benefit, physiologically futile, and merely prolonged dying. This brings us to the question of futility, something we in critical care medicine have dealt with frequently. Whether by quantitative means or qualitative definitions, defining futility has been problematic and not very helpful, and most often result in value judgments. Presently, a fair process-based approach to futility is recommended, both by the Council of Ethical and Judicial Affairs of the American Medical Association, as well as in a joint statement from the critical care societies, including ATS, CHEST, the Society of Critical Care Medicine, the European Society of Intensive Care Medicine. The fair process approach to reviewing futility cases comes from the world of shared decision making, and it involves trying to have a much more negotiated solution to a particular problem. Number one, efforts to deliberate over and negotiate a prior understanding between the patient or proxy and physician of what is acceptable. Trying to make joint decisions at the bedside, reaching out for assistance of an individual consultant or patient representative, going to an institutional committee, such as the Ethics Committee, if disagreements are unresolvable, and considering transfer of care, if necessary. For the purpose of reference material, here is a diagram published by the American Medical Association. It's a diagram of a group of physicians in the United States, the American Medical Association, regarding fair process and futility cases, involving deliberation, refinement, trying to come to an agreement, going to higher levels of resource, either from consultants, patient representatives, ethics committees, and if all else fails, consider transfer of care with an institution, not so much possibility in pediatric critical care, or potentially transfer to another institution. It involves mainly the institution of a process. Here, for reference, is a description of a hospital policy for how to discuss conflicts related to futile treatment, and states ahead of time what process may occur or should occur when conflicts arise between what might be futile treatment. Treatment. Informed consent in pediatrics. Informed consent or permission has several components. They include disclosure with provision of information, an assessment of understanding of the person who's giving consent or permission, an assessment of competency of that person to make decisions, and an assurance that the patient has the freedom to choose among medical alternatives without coercion, the principle of voluntariness. Please remember that consent is personal, and there is a difference between making a decision for oneself or for someone else. In order to grant consent or permission, the patient or surrogate must be decisionally competent. To be competent, the patient or surrogate must be able to understand the therapy in question, can consider the risks and benefits, is able to decide on a course of action, and is able to appreciate the consequences of the choice that they make. Adults are presumed to be legally competent, and children are incompetent until the age of 18 or 21. They may be rendered competent earlier than that by means of emancipation or maturity. There is a developmental continuum, as we well know, as pediatricians. And in general, 14 years is an age which is accepted as one in which someone is able to make a reasonable decision about their health care, if not being legally competent to do so. At 14, we know they may be intellectually capable. Of course, at 14, they may also not be so emotionally capable. A mature minor is an older adolescent who is rendered mature minor by judicial decision, who can make care decisions exclusively for their own benefit, when the care is in the mainstream medical practice. The minor is informed of the risks and benefits, is capable of informed consent, and consent must be voluntary. There are minor consent laws, which permit minors to consent for aspects of their own health care. They exist in 14 states. Every law is different. In 33 states, the parent or guardian has the right of consent. The basis for minor consent laws can either be legal status, either through emancipation, if someone is married in the armed services, pregnant, living from the parents, or incarcerated, or certainly service-based. And this often refers to reproductive care, treatment of STIs, reportable disease care, HIV AIDS, emergency care, sexual assault, drug and alcohol counseling. The basis for minor consent laws is the right to consent. The principle of assent of a minor patient. Federal regulations define assent as a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. It empowers children to the extent of their decisional capacity. It takes into consideration a developmentally appropriate One should tell the patient what they can expect with tests and treatments. And there should be an assessment of the patient's understanding of the situation and the factors influencing how he or she is responding. A question. As part of a research project being carried out by a third year GI fellow, a blood sample is to be drawn at five o'clock in the morning for the first five post-operative days after liver transplant. The parents of a seven-year-old patient signed consent for this IRB approved study prior to surgery. The patient participated in an assent discussion and assented to participate having been informed there was a chance he would undergo a needle stick if there was no other way to obtain blood. On post-operative day four, there is no other way to obtain blood other than needle stick. The patient refuses. What should be done? Number one, call the parents and have them convince the patient to prevent, permit phlebotomy. Number two, call the GI fellow and have them draw the blood. Three, notify the IRB. Number four, hold the patient down and draw the blood sample. Number five, accept his refusal. The answer here is five, accept his refusal. Children have additional regulatory protections with regard to engaging in research. In general, permission of the parents or guardians in assent of a minor subject are considered adequate substitute for consent. Assent is not required in life-threatening illness research and it is very important that documentation be clear. Advanced directives include living wills in which patient expresses their wishes ahead of time. And healthcare durable power of attorney in which a proxy is established who will make decisions during a healthcare situation. The Patient Self-Determination Act of 1991 requires Medicare and Medicaid participating institutions to inform patients of their rights to formulate advanced directives. What about emergency treatment? In a 2011 AAP policy statement, the consent for emergency medical services for children and adolescents was discussed. Under the emergency exception rule, a medical professional may presume consent and proceed with appropriate treatment and transport if the following four conditions are met. The child is suffering from an emergent condition that places his or her life or health in danger. The legal guardian is unavailable or unable to provide consent for treatment or transport. Treatment or transport cannot be safely delayed until consent can be obtained. And the professional administers only treatment for emergent conditions that pose an immediate threat to the child. Can children refuse treatment? The case of star child Abraham Chiricks involved a 15-year-old and his parents who refused additional chemotherapy recommended by their physicians because of the adverse effects he had suffered previously. They chose prayer and herbal remedy. They were threatened with loss of custody. They had a child in the womb. They chose prayer and herbal remedy. They were threatened with loss of custody. They had lots of support in the media and a compromise was reached. They stayed under the care of the oncologist. They received herbal treatments along with some RT, but no chemo. In the locale where this case occurred, a law known as Abraham's Law was put into effect. In it, it was stated that parents of a child at least 14 years of age with a life-threatening condition could refuse medically recommended treatment. That is, would not be referred to Child Protective Services for neglect, provided the parents and child made the decision jointly. provided the parents and child made the decision jointly. The child is sufficiently mature to have an informed opinion on the treatment. Other treatments have been considered and they believe in good faith that their choice is in the child's best interest. This is the case of a 14-year-old who had professed membership to the Jehovah's Witness religion who refused transfusion while undergoing therapy for leukemia. A judge stated that although the child was in the 8th grade, was old enough to know that refusing blood transfusions might amount to a death sentence and he had the right to make that decision. Some issues regarding pediatric intensive care and the presence in the future. Keeping the desperately ill alive, extreme vitalism, just the population of the future. Have we gone too far with parental autonomy? I'd just like to quote, the concept for autonomy only invokes a negative right, the right to refuse an intervention. It is not a positive right and the right to demand a treatment that is not being offered. When is death an acceptable option? The era of ECMO, corporeal life support, any CPR, and moral distress. Moral distress may be one of the most severe problems that we will face in our world in intensive care. An ethical dilemma occurs when more than one ethically and morally acceptable path is present. Distress occurs when someone knows the correct path, but that is not what is being taken. Barriers or constraints exist to following the right path. Someone may be told what to do against their better judgment. This comes from the nursing literature initially, but now exists as well in the medical literature. The foundation of this principle comes from the work published in 2005 by a group of pediatric ethicists, in which they stated that 54% of house officers and substantial portions of attending physicians and nurses reported, at times I've acted against my conscience in providing treatment to children in my care. 38% of critical care attending physicians agreed and 48% of critical care nurses. In the midst of an ethical dilemma, with a sense of disempowerment and a sense of inappropriate care in which I or we know what to do, but that's not what's being done, that results in moral distress. Episodes of moral distress may fade, but often leave a moral residue. An accumulation of those moral residues over time will result in the burnout syndrome. Moral distress in pediatric intensive care has been described by Garris. The critical care societies published a consensus statement on the burnout syndrome in the critical care health care professionals. This was in 2016. And then came SARS-CoV-2. There's unlikely to be questions on the board of directors on COVID, but this has influenced many of the ways we think about ethics in medicine. Ventilator rationing became a reality. Crisis standards of care were implicated. I was referred to the New York State Ventilator Allocation Guidelines and asked to create principles of who and who would not get a mechanical ventilator in severe respiratory failure. Dr. Trug from Harvard wrote that whereas this type of rationing may not be unusual in countries that tragically have a chronic shortage of essential ICU care, it is unprecedented for most physicians who practice in well-resourced countries. Multiple articles, some referenced here, discussed biomedical ethics in the face of COVID-19. These are here for your reference. The Hastings Center, in addition, published the ethical framework for health care institutions responding to novel coronavirus SARS-CoV-2, guidelines for institutional ethics services responding to COVID-19, managing uncertainty, safeguarding communities, and guiding practice. Emanuel et al. wrote on the fair allocation of scarce medical resources in the time of COVID-19. Here are some of the guidelines that Emanuel et al. described for distributing rare resources and therapeutics to patients in the face of the COVID pandemic, period. And with this, I bring my presentation to a conclusion. I wish everyone good luck in taking their board exam or recertification. And I hope that this brief review of some issues of biomedical ethics in critical care medicine will be helpful to you. Thank you very

pediatric critical care medicine

ethical issues

end-of-life care

clinical ethics

consent and assent

surrogate decision-making

bioethics in pediatrics